SUPREME-DM (Diabetes Mellitis) Treatment Study

NCT02192255 | Completed

• 1 other identifier: 10-018
• Study Type: interventional
• Target: 2,378
• Locations: 1 country
• Sites: 1

Brief Summary

This multisite pragmatic clinical trial was designed to assess the effectiveness of a single scripted telephone call to diabetes patients who (a) were currently above recommended clinical goals for glucose, blood pressure, or lipids, and (b) had recently been prescribed a new medication for that specific clinical domain. The goals of the intervention were to improve primary adherence and persistence to the newly prescribed medication and to improve control of glucose, blood pressure, and lipids.

Conditions

Diabetes

Keywords

diabetes type 2; primary care; chronic disease care improvement; adherence, randomized trial; BP control; lipid control; glucose control; natural language processing.

Outcome Measures

Primary Outcomes (2)

• 60 day Medication Adherence

  In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) \>= 8%, blood pressure \>= 140/90 mm Hg, or low-density lipoprotein cholesterol \>=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (a) first medication fill within 60 days of prescription,

  60 days

• 120 day medication adherence

  In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who were recently prescribed a new class of medication for elevated glycated hemoglobin (A1c) \>= 8%, Blood pressure \>= 140/90 mm Hg, or low-density lipoprotein cholesterol \>=100 mg/dL, to receive (a) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or (b) usual care. Hierarchical linear and logistic regression models were used to assess impact on (b) \>=2 medication fills within 180 days of prescription,

  120 days

Secondary Outcomes (1)

• Composite Control Level of Blood pressure, A1c and/or LDL

  180 days

Study Arms (2)

Intervention phone call

EXPERIMENTAL

The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted \< than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.

Behavioral: Intervention Phone Call

Control arm - usual care

NO INTERVENTION

Those in the control arm received usual care.

Interventions

Intervention Phone Call BEHAVIORAL

The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted \< than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.

Intervention phone call

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At each clinical intervention site, study subjects were selected if they:
• were age 18-75 years
• met study criteria for diabetes mellitus before study enrollment
• received clinical care at a designated clinic or medical center involved in this study for at least 15 months before enrollment
• were prescribed a new class of medication (not filled in the past 180 days) for A1c, BP, or LDL that was uncontrolled at the time of medication prescription (A1c\>=8%, systolic BP\>= 140 mm Hg, or LDL \>=100 mg/dL).

You may not qualify if:

• Study subjects were excluded if they were younger than 18 years of age
• Older than 75 years of age
• Did not have evidence of diabetes mellitus prior to study enrollment
• Were not receiving care at a clinic site involved in this study for at least 15 months before enrollment
• Did not have prescribed a new class of medication for uncontrolled A1c, BP or LDL.

Sponsors & Collaborators

• HealthPartners Institute: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

HealthPartners Institute for Education and Research

Minneapolis, Minnesota, 55425, United States

Location

Related Publications (1)

• O'Connor PJ, Schmittdiel JA, Pathak RD, Harris RI, Newton KM, Ohnsorg KA, Heisler M, Sterrett AT, Xu S, Dyer WT, Raebel MA, Thomas A, Schroeder EB, Desai JR, Steiner JF. Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes. Diabetes Care. 2014 Dec;37(12):3317-24. doi: 10.2337/dc14-0596. Epub 2014 Oct 14.

  PMID: 25315207 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Patrick J. O'Connor, MD, MPH

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: July 16, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (1)